The ROME (Retrospective Observational Multicenter study on Eslicarbazepine) study: Efficacy and behavioural effects of Eslicarbazepine acetate as adjunctive therapy for adults with partial onset seizures in real life

Seizure. 2018 May:58:35-40. doi: 10.1016/j.seizure.2018.03.028. Epub 2018 Mar 30.

Abstract

Purpose: Eslicarbazepine acetate (ESL) is a third-generation member of the dibenzazepine family approved in 2009 by the European Medicines Agency with the indication of adjunctive therapy in adult people with partial-onset seizures (PPOS). We aimed at assessing the ESL impact on seizure frequency and quality of life in PPOS with a particular attention to sleepiness and depression.

Methods: We evaluated 50 adult PPOS (>18 years; 48 ± 14 years-old; 23 males) treated with adjunctive ESL for ≥2months with a retrospective multi-centric design. Clinical files of the last 2 years were reviewed checking for monthly seizure frequency, treatment retention rate, adverse drug reactions (ADRs), concomitant anti-epileptic drugs and behavioural scales for sleepiness (Stanford Sleepiness Scale, SSS, and Epworth Sleepiness Scale, ESS), depression (Beck Depression Inventory-II, BDI) and overall quality of life (QOLIE-31).

Results: At the end of 96 ± 28 days of ESL treatment, the mean seizure reduction was 56%; 60% of patients had seizure reduction above 50%, with a 31% of the whole population becoming seizure free. We reported 16 ADRs with 4 hyponatremia. Retention rate was 76%. Patient reported less sleepiness after ESL (SSS, p = 0.031; ESS, p = 0.0000002). Before ESL, 38% of patients had pathologic BDI scores, which normalized in most of them (73%) after ESL (BDI improvement, p = 0.000012). These scores resulted in an amelioration of quality of life (QOLIE-31, p = 0.000002).

Conclusions: ESL is a safe and effective anti-epileptic drug in a real life scenario, with an excellent behavioural profile for the overall quality of life and, in particular, for sleepiness and depression.

Keywords: Anti-epileptic drug; Beck depression inventory II; Drug-resistant; Epilpepsy; Epworth sleepiness scale; Eslicarbazepine; Partial onset seizures; Quality of life.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Anticonvulsants / adverse effects
  • Anticonvulsants / therapeutic use*
  • Antidepressive Agents / adverse effects
  • Antidepressive Agents / therapeutic use
  • Depression / drug therapy
  • Dibenzazepines / adverse effects
  • Dibenzazepines / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Humans
  • Male
  • Middle Aged
  • Quality of Life
  • Retrospective Studies
  • Seizures / drug therapy*
  • Seizures / psychology
  • Sleep / drug effects
  • Treatment Outcome
  • Wakefulness-Promoting Agents / adverse effects
  • Wakefulness-Promoting Agents / therapeutic use

Substances

  • Anticonvulsants
  • Antidepressive Agents
  • Dibenzazepines
  • Wakefulness-Promoting Agents
  • eslicarbazepine acetate